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QTEXX Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

QTEXX Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 - 99 Standard Specification for Rubber Examination Gloves. They are blue or natural white in colour.

Here's an analysis of the provided text regarding the QTEXX Pre-Powdered Nitrile Examination Gloves, broken down into the requested categories. Please note that the document is a 510(k) summary for a medical glove, which is a low-risk device. As such, the types of studies and information typically found for higher-risk diagnostic or AI-driven devices are not present.

1. A table of acceptance criteria and the reported device performance

For medical gloves, "acceptance criteria" are typically the standards and specifications they must meet. In this case, the primary standard is ASTM D 3578-99.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: This information is not explicitly provided in the summary. For non-clinical tests like those specified in ASTM D 3578-99, specific sampling plans are typically outlined within the standard itself.
• Data Provenance: The tests were performed by the manufacturer, LATEXX PARTNERS BERHAD, located in Kamunting, Perak, Malaysia. The testing is non-clinical/laboratory-based.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This is not applicable for a medical glove submission. "Ground truth" in the context of medical gloves refers to objective physical and chemical testing against established standards (ASTM, FDA regulations) as well as animal model biocompatibility tests, not expert interpretation of diagnostic data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable for a medical glove submission. Adjudication methods are typically used in clinical studies or for subjective assessments (e.g., image interpretation), not for standardized physical property testing of manufactured goods.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This is not applicable for a medical glove submission. MRMC studies are used for diagnostic devices, particularly those involving human interpretation of data, often in conjunction with AI. This is a low-risk medical device (examination glove) where AI assistance or human reader performance improvement is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. This device is a physical medical product, not an algorithm or AI system.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for medical gloves is established by:

• Established Industry Standards: Primarily ASTM D 3578-99, which defines the physical and performance requirements (e.g., tensile strength, elongation, barrier properties, freedom from holes).
• Regulatory Requirements: 21 CFR 800.20, which deals with specific performance characteristics like freedom from holes.
• Biocompatibility Testing: Animal models (rabbit for primary skin irritation, guinea pig for delayed contact sensitization) provide objective data on biological response.
• Chemical Testing: USP iodine test for starch presence.

8. The sample size for the training set

This is not applicable. There is no "training set" in the context of a manufactured medical glove. The product's design and manufacturing process are developed to meet the specified standards, not "trained" on data.

9. How the ground truth for the training set was established

This is not applicable. As there is no training set, there is no ground truth for it.

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HEALTH + AID ° PREMIUM Pre - Powdered Nitrile Examination Glove is a single use device intended for medical purposes that is worn on the hand of health care and similar personnel to prevent contamination between the health care personnel and the patient.

HEALTH + AID ® PREMIUM Pre - Powdered Nitrile Examination Gloves meet the current specifications listed under the ASTM Specification D 3578 -- 95, Standard Specificatio for Rubber Examination Gloves. They are blu or natural white in colour.

The provided text describes a 510(k) summary for HEALTH + AID® PREMIUM PRE - POWDERED NITRILE EXAMINATION GLOVES. This document is a regulatory submission for a medical device (examination gloves) and focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a clinical study on an AI/ML powered device.

Therefore, many of the requested details, such as those related to AI/ML powered devices, ground truth, expert adjudication, multi-reader multi-case studies, and specific accuracy metrics, are not applicable or not present in this document.

However, I can extract information related to the acceptance criteria for these gloves and the nonclinical testing performed to meet those criteria.

Acceptance Criteria and Reported Device Performance

1. Table of Acceptance Criteria and the Reported Device Performance:

Note: The document explicitly states that the device meets "all the current specifications listed under the ASTM Specification D 3578 – 95, Standard Specification for Rubber Examination Gloves," even though earlier text states the predicate device met D 3578-95 except for tensile strength and ultimate elongation. This suggests the new device is being compared against the full D 3578-95 standard, or the "EXCEPT" clause was hyper-specific to the predicate claim and not the current device's compliance. Given the "Brief Discussion of Nonclinical Tests" states "Gloves meet all the current specifications listed under the ASTM Specification D 3578 - 95," this is the performance claim.

Additional Information (as requested, but largely N/A for this document type):

2. Sample size used for the test set and the data provenance:

• Not applicable. This document describes nonclinical, physical, and biocompatibility testing of a physical product (gloves), not a software device or an AI/ML algorithm that would use a test set of data in the common sense. The testing is performed on samples of the manufactured gloves. The document does not specify sample sizes for these tests, nor data provenance in terms of country of origin for a data set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable. "Ground truth" in the context of expert consensus is not relevant here. The ground truth for glove performance is defined by standardized test methods (e.g., ASTM D 3578-95) and the objective measurements derived from them. Biocompatibility tests are performed by qualified laboratories and personnel following established protocols, but the concept of "experts establishing ground truth for a test set" like in AI/ML is not applicable.

4. Adjudication method for the test set:

• Not applicable. This concept relates to conflicting interpretations from multiple experts on a diagnostic image or data point. For physical product testing as described, the results are typically quantitative measurements that either pass or fail a predefined limit.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• Not applicable. This is a physical product (examination gloves), not an AI-powered diagnostic device. No MRMC study was conducted.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

• Not applicable. This is a physical product (examination gloves), not an algorithm or software.

7. The type of ground truth used:

• For physical properties and barrier integrity: Objective measurements against ASTM standards.
• For biocompatibility: Animal study results (irritation, sensitization) and chemical tests (starch presence). These are considered direct evidence of the device's properties as per regulatory guidelines at the time.

8. The sample size for the training set:

• Not applicable. There is no "training set" in the context of an AI/ML algorithm for this device. The manufacturing process itself (and quality control checks on manufactured batches) could be seen as analogous to continuous learning and validation, but not in the AI/ML sense.

9. How the ground truth for the training set was established:

• Not applicable. As there is no training set for an AI/ML algorithm, this question is not relevant.

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A Medical glove is worn on the hand of healthcare and similar personnel to prevent contamination between healthcare personnel and patient.

Pre-powdered Nitrile Examination Gloves

The document is a 510(k) clearance letter from the FDA for "Pre-Powdered Nitrile Examination Gloves" manufactured by P.T. Latexindo Tobaperkasa. It states that the device is substantially equivalent to devices marketed before May 28, 1976, and therefore can be marketed.

This document is a regulatory clearance letter, not a study report or technical specification detailing performance criteria and a study proving those criteria were met. Therefore, none of the requested information about acceptance criteria, device performance, study details, sample sizes, ground truth, expert involvement, adjudication, or MRMC studies can be extracted from this document.

The letter confirms the device's classification and substantial equivalence but does not provide the technical data or study results that would typically be included in a submission demonstrating performance against specific acceptance criteria.

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